Stellenbeschreibung

Senior Global Regulatory Affairs Specialist-Permanent-Stuttgart- €65.000Optimus search is in partnership with a global pharmaceutical company with it's HQ in Stuttgart. My client is looking for a Global Regulatory Affairs Specialist specialised in CMC for Europe and Rest of the World countries. The ideal candidate will have 2-3 years' experience in CMC compliance, particularly with modules 2,3,4 and 5.  Responsibilities: ·         Ensure regulatory compliance at a national and international level, in accordance with EU and non-EU legislation ·         In charge with maintenance activities: examination of existing authorizations and organisation and management of Variations and Renewals ·         Manage the full CMC compliance process according to the given timelines ·          Organization and coordination of new projects in accordance with the national, EU and RoW legislations·         Will be the interface of cross-functional departments, such as creation and control of packaging texts, labeling, quality, R&D, etc.             Requirements:   ·         A good degree in Pharmacy or a Life Sciences related discipline ·         Excellent knowledge of legal regulations with regards to drug approvals ·         Minimum 2-3 years’ experience in a Regulatory Affairs environment: CMC preferred ·         Experience in compliance, particularly Modules 2,3,4,5. ·         Excellent knowledge of technical and functional requirements for National, International areas (EU, Non-EU) ·         Sound knowledge of English and German. Spanish, French, Russian knowledge is highly desired   The company is looking for the right person to join their international team and help with global projects. If you believe that this role is suitable for your experience and career perspective, do not hesitate to apply.